Payload Information

Payload Information

Prof. Feng ZHU (zhufeng@zju.edu.cn)

Prof. Xiaowu DONG (dongxw@zju.edu.cn)

Prof. Luo FANG (fangluo@zjcc.org.cn)

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General Information of This Payload

Each Antibody-drug Conjugate Related to This Payload

Full Information of The Activity Data of The ADC(s) Related to This Payload

telisotuzumab adizutecan [Phase 3]

ADC Info

Identified from the Human Clinical Data

Click To Hide/Show 8 Activity Data Related to This Level

Experiment 1 Reporting the Activity Date of This ADC				[1]
Efficacy Data	Objective Response Rate (ORR)	18%
Patients Enrolled	Eligibility varies by study part but generally requires advanced solid tumors (NSCLC, GEA, CRC, or MET-altered tumors) with progression on standard therapies, ECOG PS 0-1, and adequate organ function. Key exclusions include ILD/pneumonitis history, active lung diseases, and prior TAS-102/regorafenib treatment for Part 7 CRC participants.
*Related Clinical Trial*
NCT Number	NCT05029882	Phase Status	PHASE1
Clinical Description	A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors
Primary Endpoint	The primary efficacy endpoint is Objective Response Rate (ORR) evaluated by the investigator per RECIST v1.1 over 24 months, defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR).
Other Endpoint	Secondary endpoints include Duration of Response (DOR) for participants with confirmed CR/PR, Progression-Free Survival (PFS), and Overall Survival (OS), all assessed per RECIST v1.1 criteria by investigator review over a 24-month period.
Experiment 2 Reporting the Activity Date of This ADC				[2]
Patients Enrolled	Eligible participants must have measurable disease of specified tumor types (HCC, PDAC, HNSCC etc.) and meet protocol-defined lab criteria. Key exclusions include prior anticancer therapy within 28 days, active ILD/pneumonitis, untreated CNS metastases, concurrent autoimmune disorders with pulmonary involvement, and unresolved Grade >1 toxicities from prior treatments. Click to Show/Hide
*Related Clinical Trial*
NCT Number	NCT06084481	Phase Status	PHASE1
Clinical Description	A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
Primary Endpoint	The primary efficacy endpoint is Objective Response Rate (ORR) assessed over 24 months, defined as the proportion of participants achieving confirmed PR or better per RECIST 1.1 criteria.
Other Endpoint	Secondary objectives include evaluating Duration of Response (DOR), Clinical Benefit Rate (CBR), Progression-Free Survival (PFS), and Overall Survival (OS). Pharmacokinetic parameters (Cmax, Tmax, AUC) of ABBV-400, total ADC concentration, Top1 inhibitor payload levels, and immunogenicity (ADA/nADA) will be assessed throughout 24 months.
Experiment 3 Reporting the Activity Date of This ADC				[3]
Patients Enrolled	Eligible participants must have histologically confirmed unresectable mCRC with measurable disease, having progressed on only one first-line systemic metastatic treatment. Exclusion criteria include BRAF V600E mutation, dMMR+/MSI-H status, and recent anticancer therapies within 28 days or 5 half-lives prior to study initiation.
*Related Clinical Trial*
NCT Number	NCT06107413	Phase Status	PHASE2
Clinical Description	A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer
Primary Endpoint	The study will evaluate Objective Response (OR) rate within 24 weeks per RECIST 1.1, Progression-Free Survival (PFS) up to 11 months, and monitor Adverse Events (AEs) for up to 3 years to assess safety and efficacy.
Other Endpoint	Additional endpoints include Duration of Response (DOR) up to 7 months, Overall Survival (OS) up to 3 years, and Best Overall Response (BOR) achievement within 18 weeks, all assessed according to RECIST v1.1 criteria.
Experiment 4 Reporting the Activity Date of This ADC				[4]
Patients Enrolled	Eligible participants must have ECOG PS 0-1, confirmed advanced/metastatic mCRC without BRAF V600E or dMMR+/MSI-H status, and measurable disease. Stage 2 requires c-Met protein expression (3+ intensity, ≥10% tumor cells). Key exclusions include recent cardiac events, prior c-Met antibody/ADC therapy, ILD/pneumonitis history, unresolved toxicities (Grade >1), untreated CNS metastases, or concurrent autoimmune/inflammatory lung disorders. Click to Show/Hide
*Related Clinical Trial*
NCT Number	NCT06464692	Phase Status	PHASE1\|\|\|PHASE2
Clinical Description	A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of ABBV-400 in Chinese Subjects With Unresectable Locally Advanced/Metastatic Colorectal Cancer
Primary Endpoint	The study will assess Dose-Limiting Toxicities (DLTs), pharmacokinetic parameters (Cmax, Tmax, AUC), total antibody levels, and unconjugated payload of Telisotuzumab Adizutecan over 24 months, with DLTs defined as severe hematologic toxicities or pneumonitis conditions unresponsive to treatment.
Other Endpoint	Efficacy endpoints include Objective Response (OR) rate, Duration of Response (DoR), Best Overall Response (BOR), Progression-Free Survival (PFS), and Overall Survival (OS), all evaluated per RECIST v1.1 over a 24-month period.
Experiment 5 Reporting the Activity Date of This ADC				[5]
Patients Enrolled	Eligible participants must have ECOG PS 0-1, ≥12 weeks life expectancy, RECIST-measurable disease. Key exclusions include prior c-MET antibody/ADC therapy, hypersensitivity to bevacizumab/trifluridine-tipiracil, and active infections per protocol.
*Related Clinical Trial*
NCT Number	NCT06614192	Phase Status	PHASE3
Clinical Description	AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Primary Endpoint	The study evaluates safety (AEs, vital signs, ECGs, lab abnormalities), pharmacokinetics (Cmax, Tmax, AUC, t1/2, ADC, unconjugated Top1 inhibitor), immunogenicity (ADAs/nADAs) and efficacy (OR, PFS, OS, DOR, DC) of ABBV-400 in Stage 1, with Stage 2 focusing on efficacy and patient-reported physical function/diarrhea/QoL via EORTC QLQ-C30 over 4 years. Click to Show/Hide
Other Endpoint	Efficacy is assessed by BICR and investigators per RECIST v1.1, including OR, PFS, DOR, DC (CR/PR/SD), and OS in both stages. PK parameters cover total antibody, payload, ADAs. Stage 2 tracks changes in physical function, diarrhea and GHS/QoL between ABBV-400 and SOC arms.
Experiment 6 Reporting the Activity Date of This ADC				[6]
Patients Enrolled	Eligible participants must have metastatic HER2-negative gastric/GEJ/esophageal adenocarcinoma, measurable disease (RECIST 1.1), ECOG PS 0-1, and known PD-L1 status. Key exclusions are prior systemic therapy for metastatic disease and significant pre-existing lung conditions as per protocol specifications.
*Related Clinical Trial*
NCT Number	NCT06628310	Phase Status	PHASE2
Clinical Description	A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)
Primary Endpoint	The primary endpoints include investigator-assessed Progression-Free Survival (PFS) from first treatment dose to radiographic progression or death per RECIST 1.1, and Objective Response Rate (ORR) of confirmed complete/partial responses, evaluated over approximately 6 years.
Other Endpoint	Secondary efficacy measures involve Disease Control Rate (DCR - CR/PR/SD lasting ≥16 weeks), Duration of Response (DOR), and Overall Survival (OS) from treatment initiation, all assessed per RECIST 1.1 by investigators during the 6-year study period.
Experiment 7 Reporting the Activity Date of This ADC				[7]
Patients Enrolled	Eligibility requires histologically confirmed advanced/metastatic non-squamous NSCLC (Part 1: ≤1 prior systemic therapy; Part 2: treatment-naive with no actionable mutations), measurable disease per RECIST v1.1, documented PD-L1 status, and adequate organ function, excluding those with uncontrolled CNS metastases or active ILD/pneumonitis requiring steroids. Click to Show/Hide
*Related Clinical Trial*
NCT Number	NCT06772623	Phase Status	PHASE1\|\|\|PHASE2
Clinical Description	An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations
Primary Endpoint	Part 1 evaluates Dose-Limiting Toxicities (DLTs) of Telisotuzumab Adizutecan within 84 days, while Part 2's primary focus is Objective Response (OR) per blinded independent central review (BICR) using RECIST v1.1 over 33 months, along with monitoring adverse events (AEs) throughout the study period.
Other Endpoint	Secondary endpoints for Part 2 include BICR-assessed Progression-Free Survival (PFS), Duration of Response (DOR), and Disease Control (DC) for at least 12 weeks, with additional investigator-assessed efficacy measures and PD-L1 subgroup analyses spanning OR, PFS, OS, DOR, and DC, all evaluated over 33 months.
Experiment 8 Reporting the Activity Date of This ADC				[8]
*Related Clinical Trial*
NCT Number	NCT05982873	Phase Status	N.A.
Clinical Description	Expanded Access to ABBV-400

References

Ref 1	Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab
Ref 2	Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Ref 3	Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
Ref 4	Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer
Ref 5	A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Ref 6	A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Ref 7	A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
Ref 8	Expanded Access to ABBV-400

Payload ID

DNA topoisomerase 1 (TOP1)

Target Info